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Sr. Engineer, Quality Operations - Medical Device

  • Job type: Permanent
  • Location: Miami
  • Salary: Competitive
  • Job reference: MERZ04142018350
  • Sector: Quality Assurance, EPM Scientific, Quality
  • Date posted: 14/04/2018
  • Medical Device Company - Endovascular
  • Miami, FL
  • $80K - $95K + Bonus + Benefits + Excellent Career Growth
A global medical device company is looking to hire a Senior Engineer, Quality Operations to join the Quality Assurance team! This role will report to the Senior Manager, Quality Operations. This company is one of the world leaders committed to manufacturing, developing, and distributing high-quality technology and products for endovascular solutions. This medical device company is family oriented, has a great work-life culture, and has been expanding in size!

The Senior Engineer, Quality Operations will play a key role in supporting the quality engineering operations - in-process and finished products - as well as maintaining methods and processes in compliance with regulatory and company standards. The Sr. Engineer of Quality Operations will report on the performance of the assigned quality areas. This individual will develop: quality standards, controls, product & process qualifications, reports, and validation protocols for new and existing manufacturing production lines. The Senior Engineer, Quality Operations will review non-conformances and perform risk assessments.

The Senior Engineer, Quality Operations will be responsible for the following duties:
  • Report, identify and monitor non-conformances; participate in non-conformance process to ensure documentation stages are completed in a timely manner
  • Develop Quality Standards and Quality Instructions
  • Perform process or product failure investigations and implement CAPA for preventative reoccurrences 
  • Support the development, validation and implementation of Test Methods 
  • Provide Quality Assurance support; respond to Internal Audits; take appropriate actions in relation to Complaint Investigations, CAPAs, Nonconformances, etc 
  • Lead and perform risk assessment exercises supporting validation activities 
  • Interact and collaborate with cross functional teams (Product Support, Manufacturing, R&D) to support products for design and process improvements, as well as new product installations
  • Provide suggestions and ability to implement, review, & approve engineering changes regarding product life cycle 

The Sr. Engineer, Quality Operations will have the following minimum requirements:
  • Bachelor’s degree in Biomedical, Mechanical, or Electrical Engineering
  • 5+ Years experience in Medical Device Industry - Quality Assurance  
  • 5+ Years experience in Quality Engineering or Manufacturing Engineering in relation to validations 
  • Strong working knowledge of ISO 13485, ISO 14971, and 21 CFR 820
  • Must have prior experience handling nonconforming events 
  • Six Sigma Certification a plus
  • ASQ Quality Engineer Certification a plus
  • Hands-on professional with strong leadership skills
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